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The “final curtain” on CCSVI and Liberation Therapy for Multiple Sclerosis?

Submitted by admin on Sun, 01/15/2012 - 23:40

BY PAMELA FAYERMAN

The premise that constricted neck veins are to be blame for Multiple Sclerosis (MS) has been dealt a fatal blow by a University of BC-led study published in the Lancet.

The new study comes to the opposite conclusion of the Italian doctor, Paolo Zamboni, who coined the term chronic cerebrospinal venous insufficiency (CCSVI)when he reported in 2009 that virtually all MS patients have the vein narrowing disorder.

They can benefit, Zamboni still maintains, from having their neck veins dilated through an angioplasty procedure called “Liberation” therapy, meant to improve blood flow between the brain and the heart and clear out iron deposits.

Using Dr. Paolo Zamboni’s own “cookbook” of methods, equipment and even his direct instruction to technologists who went to Italy to learn from him, Canadian researchers could not replicate the Italian doctor’s stunning results. Indeed, they discovered that MS patients and healthy controls shared the same prevalence of vein constriction, suggesting it’s nothing more than dynamic, typical vein physiology.

Dr. Anthony Traboulsee. Photo: UBC

As lead researcher Dr. Anthony Traboulsee commented in an interview, there’s plenty of variability — and “built-in redundancy” — in human veins (as opposed to arteries). The study proves the cause of MS cannot be attributed to the shape of cervical (neck) veins, he said, while adding that in medicine, even wrong theories have led to important discoveries.

Since Zamboni’s theory remains unvalidated in a handful of North American studies, confusion and controversy will surely continue. Indeed, UBC’s Traboulsee concedes that half of patients who’ve had vein stretching procedures (after MRI or ultrasound imaging at private clinics) have anecdotally reported quality of life improvements and some symptom (fatigue, brain fog) relief.

In a conference call with journalists, Traboulsee said vein dilation could trigger a placebo effect or possibly a true treatment effect through stimulation of nerves damaged by the inflammation that is because of stimulation of nerves damaged by chronic inflammation.

“I really don’t know, we could discount it as a placebo effect but that’s a bit patronizing to people.”

Unlike Zamboni’s poorly designed study, the $450,000 research study on 177 adults is randomized, controlled, blinded, and the first ever to use two “gold standard” imaging modalities. The 13 researchers from UBC and the University of Saskatchewan assessed participants’ jugular and azygous veins with two different imaging methods meant to directly image the internal architecture of veins — catheter venography (a dye-assisted vein x-ray similar to angiograms) as well as ultrasound.

In 79 MS patients, 55 non-affected siblings and 43 unrelated healthy controls, they found that venous narrowing of more than 50 per cent in any major vein existed in 74 per cent of MS patients, 70 per cent of healthy controls and 66 per cent of MS siblings.

When venography alone was used, and Zamboni’s own strict criteria of CCSVI deployed, the contradictory results were even more pronounced: only one participant in each arm of the study had vein stenosis (narrowing). That contradicts Zamboni’s theory that all MS patients have it.

The study is critically important since MS patients demanded it and because MS is a leading cause of disability in Canada, with over 60,000 affected by it.

Over the past four years, Traboulsee estimates up to 5,000 Canadian patients

(300 in BC) have gone abroad to get the angioplasty at for-profit medical centres in the U.S. and elsewhere. Some patients who also had stents placed inside the veins to keep them propped open died as a result of complications. Desperate for any relief, MS have been spurred on by positive testimonials widely circulated on social media sites.

Traboulsee said he perceives there’s been a recent slowdown in the number of MS patients seeking the imaging studies and followup treatment, especially since the UBC study is not the first to cast doubt on Zamboni’s theories. He cautioned MS patients still contemplating it, however, against using their hard-earned money on such procedures.

An even more ambitious $5 million study, expected to produce results in about two years, should help answer whether vein dilation can indeed provide true benefits. That study is now enrolling 100 patients in four cities — Vancouver, Winnipeg, Montreal and Quebec City. Like the current study, it is funded by the Multiple Sclerosis Society of Canada. Grant support has also been given by several foundations — Vancouver Coastal Health, Saskatoon City Hospital, Lotte and John Hecht and Wolridge.

In a Lancet commentary called “the final curtain” on CCSVI, Dr. Frieidemann Paul of Germany and Dr. Mike Wattjes of the Netherlands said CCSVI is nothing more than a phantom condition. If it actually existed, “the ultrasound findings of this study and previous studies would suggest that up to half the general and otherwise healthy population should be judged to be seriously ill because of venous insufficiency of the cervical veins.”

They suggested that the work by Traboulsee and his colleagues should be deemed conclusive and go so far as to say “it is absolutely clear that no reason exists to allocate any further resources to (CCSVI) research, be they financial or intellectual.”

Traboulsee said he thinks that assessment in too harsh.

Responding to the Lancet study, Karen Lee, vice-president, research, of the MS Society of Canada, told The Vancouver Sun in an email:

“The recent research findings from the study led by Dr. Anthony Traboulsee indicate there is no connection between CCSVI and MS. The pan-Canadian clinical trial that is already underway, led by Dr. Traboulsee, will continue to investigate whether venous dilation procedures could be beneficial for treatment of MS symptoms.

Dr. Traboulsee remains committed to evaluating CCSVI procedures with robust methods and utilizing patient-focused outcomes. We respect and honour the personal health care decisions of those who live with MS and remain committed to funding research that will answer the questions of those who live with the disease.”

Jennifer Sweeney, a Vancouver resident who was diagnosed with MS nearly a year ago, said the study is confounding since she knows of so many MS patients whose symptoms have improved from having angioplasty after imaging demonstrated venous abnormalities.

Jennifer Sweeney, a Vancouver resident recently diagnosed with Multiple Sclerosis, holds an imaging scan of her neck veins. She had the scan done to see if her veins are blocked. PNG photo: Ward Perrin

While she had been contemplating the angioplasty procedure in California, she’s fairly uncertain now about what to do.

“I’ve heard of so many people who’ve had amazing results. Those individual stories tell me there’s something to this theory. Why would people get better if the theory isn’t true?”

Sweeney, a 53-year old speech language pathologist, spent nearly $2,000 for an MRI at a private Vancouver clinic called Aim to determine if she had CCSVI. The report suggested she does, she said, but the clinic emphasizes on its website that the connection to MS is not only hypothetical but debatable. It also says it does not “endorse” the Liberation treatment touted by Zamboni.

Winnipeg author/ book publisher Ingeborg Boyens went to New York to have the angioplasty in 2011 after her imaging tests suggested she might benefit from the procedure. While she’s distraught by the fact she had only temporary relief of a few symptoms, she, too, wonders if a placebo effect can play that much of a role in healing.